NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
TAXOL (paclitaxel) by R-Pharm US is protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. First approved in 1992.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TAXOL (paclitaxel) is a microtubule-stabilizing chemotherapy agent that promotes assembly and prevents depolymerization of microtubules, inducing abnormal bundles that disrupt cell division. It is approved for six solid tumor indications including ovarian, breast, lung, cervical, peritoneal, and fallopian tube cancers. The drug is administered via intravenous injection and remains a foundational chemotherapy backbone in oncology.
LOE Approaching
As LOE approaches, the brand team is likely consolidating focus on core indications and defending against generic erosion rather than expansion; expect smaller team and maintenance-focused strategy.
Mechanism of Action
Protein-Bound Particles for Injectable Suspension (albumin-bound) is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
Started Sep 2026
50 enrolled
Small Cell Lung Cancer ( SCLC )
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Started Aug 2026
20 enrolled
Colon and Rectal Cancer
Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer
Started Jun 2026
30 enrolled
Pancreatic Cancer ResectablePancreatic Cancer
A Comparative Analysis of Mid- to Long-Term Outcomes: Paclitaxel-Coated Balloon With Debulking Versus Paclitaxel-Coated Balloon Alone in the Treatment of Chronic Femoropopliteal Artery Occlusions
Started Apr 2026
408 enrolled
Femoropopliteal Artery Occlusion
LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Started Apr 2026
400 enrolled
Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.